# FDA recall D-0864-2017

> **Standard Homeopathic Company** · Class I · drug recall initiated 2017-04-13.

## Product

Hyland's Baby Nighttime Teething Tablets [Belladonna 12X HPUS (0.0000000000003% alkaloids, calculated), Calcarea Phosphorica 6X HPUS, Chamomilla 6X HPUS, Coffea Cruda 6X HPUS, Magnesia Phosphorica 6X HPUS, Rheum 6X HPUS, Silicea 12X HPUS] Quick-Dissolving Tablets, 135-count bottle, Manufactured for: Hyland's, Inc., Los Angesles, CA  90061, NDC 54973-3197-1, UPC 3 54973 31971 4.

## Reason for recall

Superpotent Drug: FDA analysis found inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the product labels.

## Distribution

Nationwide in the USA and Puerto Rico.

## Key facts

- **Recall number:** D-0864-2017
- **Recalling firm:** Standard Homeopathic Company
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-04-13
- **Report date:** 2017-05-31
- **Termination date:** 2017-10-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Los Angeles, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0864-2017

## Citation

> AI Analytics. FDA recall D-0864-2017. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0864-2017. Source: US FDA. Licensed CC0.

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